(NASDAQ: DRTX) today announced that it has completed its target enrollment for DISCOVER 2 (“
nfections of the
ancomycin at an
esponse”), the second global, Phase 3 clinical trial of Durata’s lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.
DISCOVER 2 is a randomized, double-blind, double-dummy trial comparing the efficacy of dalbavancin to a regimen of vancomycin for the treatment of ABSSSI. Researchers are comparing two intravenous doses of dalbavancin given one week apart with twice daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen have an option to switch to oral linezolid after three days of vancomycin treatment.
As with DISCOVER 1, the protocol design of DISCOVER 2 is consistent with FDA’s Draft Guidance for Developing Drugs for Treatment of ABSSSI. This pivotal study is being conducted pursuant to a special protocol agreement with the U.S. Food and Drug Administration, and is also designed based on scientific advice provided by the European Medicines Agency (EMA).
“With the completion of patient enrollment for our DISCOVER 2 pivotal trial on schedule, we believe we are on track for submitting our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013,” said Durata Chief Executive Officer Paul R. Edick.
The primary outcome measure of DISCOVER 2 is a comparison of clinical response to therapy measured 48-72 hours after initiation of therapy determined by the cessation of spread of the erythema (redness) associated with the lesion, as well as the resolution of fever. The study, at 139 sites in the United States, Europe, Asia and South Africa, targeted enrollment of 740 patients.